Ireland - English - HPRA (Health Products Regulatory Authority)

actavis group ptc ehf - imatinib mesilate - film-coated tablet - 100 milligram(s) - other antineoplastic agents - antineoplastic agents, protein kinase inhibitor - imatinib actavis group is indicated for the treatment of - paediatric patients with newly diagnosed philadelphia chromosome (bcr-abl) positive (ph+) chronic myeloid leukaemia (cml) for whom bone marrow transplantation is not considered as the first line of treatment. - paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis. - adult patients with ph+ cml in blast crisis. - adult patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy. - adult patients with relapsed or refractory ph+ all as monotherapy. - adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements. - adult patients with advanced hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) with fip1l1-pdgfr
rearrangement.

Ireland - English - HPRA (Health Products Regulatory Authority)

actavis group ptc ehf - imatinib mesylate - film-coated tablet - 400 milligram(s) - other antineoplastic agents - antineoplastic agents, protein kinase inhibitor - imatinib actavis group is indicated for the treatment of - paediatric patients with newly diagnosed philadelphia chromosome (bcr-abl) positive (ph+) chronic myeloid leukaemia (cml) for whom bone marrow transplantation is not considered as the first line of treatment. - paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis. - adult patients with ph+ cml in blast crisis. - adult patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy. - adult patients with relapsed or refractory ph+ all as monotherapy. - adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements. - adult patients with advanced hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) with fip1l1-pdgfr
rearrangement.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

formula a) (thornton & ross ltd - white soft paraffin; cetostearyl alcohol; macrogol cetostearyl ether 22; liquid paraffin; chlorocresol; purified water - cutaneous cream - 150mg/1gram ; 72mg/1gram ; 18mg/1gram ; 60mg/1gram ; 1mg/1gram ; 699mg/1gram

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

eg sa-nv - potassium chloride 46,6 mg; sodium chloride 350,7 mg; macrogol 13125 mg; sodium hydrogen carbonate 178,5 mg - powder for oral solution - 13,7 g - sodium chloride 350.7 mg; potassium chloride 46.6 mg; sodium bicarbonate 178.5 mg; macrogol 3350 13125 mg - macrogol, combinations

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

eg sa-nv - sodium hydrogen carbonate 89,25 mg; macrogol 6562,5 mg; potassium chloride 23,3 mg; sodium chloride 175,35 mg - powder for oral solution - 6,9 g - sodium bicarbonate 89.25 mg; sodium chloride 175.35 mg; potassium chloride 23.3 mg; macrogol 3350 6562.5 mg - macrogol, combinations

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

nutrien ag solutions limited - diflufenican; bromoxynil present as the octanoate - emulsifiable concentrate - diflufenican anilide/aniline-nicotinanilide active 25.0 g/l; bromoxynil present as the octanoate nitrile active 250.0 g/l - herbicide

Australia - English - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - sodium chloride, quantity: 175.35 mg; macrogol 3350, quantity: 6562.5 mg; sodium bicarbonate, quantity: 89.25 mg; potassium chloride, quantity: 23.3 mg - powder, oral - excipient ingredients: acesulfame potassium - for effective relief from constipation and treatment of chronic constipation in adults and children aged 2 years and older. for resolving faecal impaction, defined as refractory constipation with faecal loading of the rectum, or the rectum and colon, confirmed by physical examination of abdomen and rectum, in adults and children 2 years and older. for prevention of recurrence of faecal impaction in children aged 2 years and older. use in children 2 years and older should be limited to 12 weeks except under medical supervision.

Australia - English - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - sodium chloride, quantity: 350.7 mg; sodium bicarbonate, quantity: 178.5 mg; potassium chloride, quantity: 46.6 mg; macrogol 3350, quantity: 13125 mg - powder, oral - excipient ingredients: acesulfame potassium; flavour - for effective relief from constipation, treatment of constipation, and treatment of faecal impaction defined as refractory constipation with faecal loading of the rectum and/or colon confirmed by the physical examination of the abdomen and rectum, in adults and children 12 years and over.

Australia - English - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - sodium chloride, quantity: 175.35 mg; sodium bicarbonate, quantity: 89.25 mg; potassium chloride, quantity: 23.3 mg; macrogol 3350, quantity: 6562.5 mg - powder, oral - excipient ingredients: acesulfame potassium; flavour - for effective relief from constipation and treatment of chronic constipation in adults and children aged 2 years and older. for resolving faecal impaction, defined as refractory constipation with faecal loading of the rectum, or the rectum and colon, confirmed by physical examination of abdomen and rectum, in adults and children 2 years and older. for prevention of recurrence of faecal impaction in children aged 2 years and older. use in children 2 years and older should be limited to 12 weeks except under medical supervision.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

a a h pharmaceuticals ltd - macrogol '3350'; potassium; chloride; sodium; bicarbonate - powder - 105gram/1litre ; 5.4mmol/1litre ; 53mmol/1litre ; 65mmol/1litre ; 17mmol/1litre